Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
METHYLPREDNISOLONE ACETATE (UNII: 43502P7F0P) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)
REMEDYREPACK INC.
METHYLPREDNISOLONE ACETATE
METHYLPREDNISOLONE ACETATE 40 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adr
DEPO-MEDROL Sterile Aqueous Suspension is available as single-dose vials in the following strengths and package sizes: NDC: 70518-0516-00 1 in 1 PACKAGE, 1 mL in 1 VIAL SINGLE USE Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
New Drug Application
DEPO-MEDROL- METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION REMEDYREPACK INC. ---------- DEPO-MEDROL (METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION, USP) SINGLE-DOSE VIAL NOT FOR INTRAVENOUS USE DESCRIPTION DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue or intralesional injection. It is available as single-dose vials in two strengths: 40 mg/mL, 80 mg/mL. Each mL of these preparations contains: Methylprednisolone acetate 40 MG 80 MG Polyethylene glycol 3350 29 mg 28 mg Myristyl-gamma-picolinium chloride 0.195 mg 0.189 mg Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range (e.g., 3.0 to 7.0.) The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)- 11,17-dihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 416.51. The structural formula is represented below: DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6- methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water. CLINICAL PHARMACOLOGY ® Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt retaining properties, are used in replacement therapy in adrenocortical deficiency states. Their synthetic analogs are used primarily for their anti-inflammatory effects in disorders of many organ systems. INDICATIONS AND USAGE A. FOR INTRAMUSCULAR ADMINISTRATION When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the tre Perskaitykite visą dokumentą